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. 2019 May 22;17(1):87.
doi: 10.1186/s12955-019-1159-0.

A DELPHI study on aspects of study design to overcome knowledge gaps on the burden of disease caused by serogroup B invasive meningococcal disease

Ole Marten  1 , Florian Koerber  2   3 , David Bloom  4 , Monika Bullinger  5 , Corinne Buysse  6 , Hannah Christensen  7 , Philippe De Wals  8 , Christian Dohna-Schwake  9 , Philipp Henneke  10 , Markus Kirchner  2 , Markus Knuf  11   12 , Burkhard Lawrenz  13   14 , Andrea L Monteiro  15   16 , Joseph Patrick Sevilla  17 , Nicolas Van de Velde  18 , Robert Welte  2 , Claire Wright  19 , Wolfgang Greiner  20
Affiliations

A DELPHI study on aspects of study design to overcome knowledge gaps on the burden of disease caused by serogroup B invasive meningococcal disease

Ole Marten et al. Health Qual Life Outcomes. .

Abstract

Background: Value assessment of vaccination programs against serogroup B invasive meningococcal disease (IMD) is on the agenda of public health authorities. Current evidence on the burden due to IMD is unfit for pinning down the nature and magnitude of the full social and economic costs of IMD for two reasons. First, the concepts and components that need to be studied are not agreed, and second, measures of the concepts that have been studied are weak and inconsistent. Thus, the economic evaluation of the available serogroup B meningococcal (MenB) vaccines is difficult. The aims of this DELPHI study are to: (1) agree on the concepts and components determining the burden of MenB diseases that need to be studied; and (2) seek consensus on appropriate methods and study designs to measure quality of life (QoL) associated with MenB induced long-term sequelae in future studies.

Methods: We designed a DELPHI questionnaire based on the findings of a recent systematic review on the QoL associated with IMD-induced long-term sequelae, and iteratively interviewed a panel of international experts, including physicians, health economists, and patient representatives. Experts were provided with a controlled feedback based on the results of the previous round.

Results: Experts reached consensus on all questions after two DELPHI rounds. Major gaps in the literature relate (i) to the classification of sequelae, which allows differentiation of severity levels, (ii) to the choice of QoL measures, and (iii) to appropriate data sources to examine long-term changes and deficits in patients' QoL.

Conclusions: Better conceptualisation of the structure of IMD-specific sequelae and of how their diverse forms of severity might impact the QoL of survivors of IMD as well as their family network and care-providers is needed to generate relevant, reliable and generalisable data on QoL in the future. The results of this DELPHI panel provide useful guidance on how to choose the study design, target population and appropriate QoL measures for future research and hence, help promote the appropriateness and consistency in study methodology and sample characteristics.

Keywords: DELPHI; Meningococcal disease; Neisseria meningitidis; Quality of life.

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Conflict of interest statement

Monika Bullinger, Corinne Buysse, Wolfgang Greiner, Markus Knuf, Ole Marten, and Andrea Monteiro declare that they have no competing interests. Markus Kirchner, Nicolas Van de Velde, and Robert Welte are employees of the GSK group of companies. Florian Koerber was employed by the GSK group of companies at the time of study conduct. Nicolas Van de Velde and Robert Welte hold shares in the GSK group of companies. To support his research on the value of vaccination, David Bloom received grants from the Bill and Melinda Gates Foundation, the World Health Organization, GSK, Merck, Pfizer, Sanofi Pasteur, and Sanofi Pasteur-MSD. He also reports personal fees from GSK, Merck, Dynavax, and Pfizer, and participation in advisory boards for the same. He received personal fees for conducting research on the value of treatment from Gilead Life Sciences as well. Hannah Christensen is affiliated to the National Institute for Health Research Health Protection Research Unit (NIHR HPRU) in Evaluation of Interventions at University of Bristol in partnership with Public Health England (PHE). She reports monies paid to her employer from AstraZeneca, GSK, IMS Health, and Sanofi Pasteur. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR, the Department of Health or Public Health England. Philippe De Wals received research grants, and reimbursements of travel expenses from vaccine manufacturers including GSK, Novartis, Sanofi Pasteur, and Pfizer, as well as from governmental agencies including the Quebec Ministry of Health and Social Services, Health Canada, and the Public Health Agency of Canada. Philippe De Wals has an advisory role as member of the Quebec immunization Committee and the (Canadian) National Advisory Committee on Immunization. Christian Dohna-Schwake reports a personal fee for GSK advisory board attendance. Philipp Henneke received reimbursements of travel expenses and honoraria from GSK, Pfizer and Abbvie, as well as from the Bill & Melinda Gates Foundation and the WHO. Burkhard Lawrenz reports personal fees from GSK, during the conduct of the study, and personal fees from MSD, Sanofi, SPMSD, and Pfizer, outside the submitted work. JP Sevilla reports personal fees from GSK, during the conduct of the study, and outside the submitted work. He is employed by Data for Decisions LLC, an economics consulting firm which contracts to perform vaccine-related economic research for many pharmaceutical companies including but not limited to GSK. He is also a Research Associate at the Harvard Chan School of Public Health (Chan School) where his research activities involve vaccine-related economic research supported by grants from pharmaceutical companies. At the Chan School, he is also a Technical Advisor on the Secretariat of the Value of Vaccines Research Network, which is funded by the Bill and Melinda Gates Foundation. Claire Wright is employed by the Meningitis Research Foundation (MRF), which has received educational grants from GSK and sponsorship for their biannual conference. She was also awarded a fee from GSK for contributing to an advisory board regarding this work. The consultancy fee was paid directly to MRF.

Figures

Fig. 1
Fig. 1
First and second round responses to Question 9. *The distinction between studies using the same or different sample(s) was not considered during the 1st round
See this image and copyright information in PMC

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